Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

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Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.

Condition or disease

Intervention/treatment

Phase

Port-Wine Stain

Device: port wine stain

Phase 1

Detailed Description:

The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.

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Ages Eligible for Study:

12 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Port Wine Stain suitable for comparison testing

Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment

Apparent good health as documented by medical history

Ability to understand and carry out subject instructions

Exclusion Criteria:

History of photodermatoses or skin cancer

Any therapy within the previous two months to the proposed port wine stain treatment sites

Current participation in any other investigational drug or device evaluation